Kocian Solc Balastik
  November 28, 2005 - Czech Republic

Free Movement of Goods: Restriction on Import of Medicines for Personal Use

Judgement of the European Court of Justice in case C-212/03 – Commission v. France, dated 26 May 2005 The Commission acted against France on the grounds that certain French rules on the importation of medicines are contrary to Article 28 of EC Treaty on the free movement of goods. The relevant national rules and administrative practice required a licence for the importation of medicines for personal use in France. Three situations were submitted for review by the European Court of Justice (hereinafter the “ECJ”). In the first situation, the importation for personal use, but not by personal transport, of medicines already authorised in France, was subject to a license. The French government argued that this requirement was a practice which was both uncertain and, in any event, concerned only 1% of such cases of importation. The ECJ concluded however that these circumstances – France did not deny the practice – did not affect the existence of the restriction itself and consequently of the breach of applicable Community legislation. The second situation concerned the importation, also for personal needs but not by personal transport, of homeopathic medicines registered in another Member State but not in France. The ECJ reiterated that the protection of human health may be a valid ground for restricting the free movement of goods. In the present situation, the importation authorisation applied to homeopathic products covered by Article 7(1) of Directive 92/73/EEC on homeopathic medicinal products, of 22 September 1992, widening the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation and administrative practice relating to medicinal products and laying down additional provisions on homeopathic medicinal products (OJ [1992] L 297 p. 8), now set out in Article 13 of Directive 2001/83 of 6 November 2001 on the Community code relating to medicinal products for human use (OJ [2001] L 311, p. 67). Article 7 (1) of Directive 92/73 essentially ensures that the dilution of the active substance of this category of homeopathic medicines guarantees their safety. The ECJ held that the French government did not provide valid human health grounds allowing a restriction of the movement of such medicines. The third situation concerned the importation into France, for personal use, of medicines not authorised in France but authorised in the Member State where they were bought. While a Member State may, in such circumstances, require importation authorisation, the Commission challenged as disproportionate the importation authorisation procedure and claimed that it was not easily accessible, not carried out within a reasonable period of time and that it applied to certain medicines not presenting a risk to public health. The ECJ noted that medicines imported for personal needs and by personal transport are not covered by the French rules under review. It also noted that the same rules apply to importation for personal needs (but not by personal transport) and for commercial purposes. The ECJ held that the measure adopted by France is not proportional to the objective pursued and that France is in breach of Community law because it has failed to adopt a less restrictive measure.